BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION 8MM-40CM UNSUPP PERIPHERAL GRAFT

    MDR report key: 6313032 · Received February 8, 2017

    Report

    Report Number
    2242352-2017-00109
    Event Type
    Malfunction
    Date Received
    February 8, 2017
    Date of Event
    January 11, 2017
    Report Date
    February 8, 2017
    Manufacturer
    MAQUET CV
    Product Code
    DSY
    PMA / PMN Number
    K131778
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET BEEN RETURNED TO MAQUET CARDIAC SURGERY FOR EVALUATION. WE ARE FOLLOWING UP WITH THE CUSTOMER FOR THE RETURN OF THE DEVICE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED. (B)(4) THE DEVICE HAS BEEN RETURNED TO THE FACTORY AND IS BEING EVALUATED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    (B)(4). CORRECTED: 510(K)# CORRECTED FROM "K153523" TO "K131778". (B)(4). A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. THERE WAS NO NONCONFORMANCE RECORDED IN THE LOT HISTORY. THE DEVICE WAS RETURNED TO FACTORY FOR INVESTIGATION. THREE PIECES OF FUSION WERE RETURNED. THE DEVICE WAS USED AS A CONNECTOR TO THE EXTRA-CORPOREAL CIRCULATION. THE TWO SMALL PIECES RETURNED HAD ZIP LOCKS AROUND THEM INDICATING THAT THESE TWO PIECES WERE USED AS CONNECTOR ENDS FOR EXTRA-CORPOREAL CIRCULATION. BOTH THESE PIECES WERE COVERED WITH BLOOD AND WERE CONNECTED TO PLASTIC CONNECTORS. THE THIRD FUSION PIECE RETURNED HAD SPECS OF BLOOD ON IT. BASED ON THE RETURN CONDITION OF THE DEVICE AND THE USAGE METHOD OF THE DEVICE, IT CAN BE CONCLUDED THAT THE DEVICE WAS USED OFF LABEL. THE REPORTED COMPLAINT IS NOT CONFIRMED. THERE ARE NO NON-CONFORMITIES WITH THE GRAFT. THE OFF LABEL USAGE OF THE DEVICE RESULTED IN PULLING OF AIR INTO THE GRAFT. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED. THE RECORDS SHOW THE DEVICE LOT CONFORMED TO ALL APPLICABLE SPECIFICATIONS AND REQUIREMENTS. THERE WERE NO NON CONFORMANCES OBSERVED.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED DURING THE PROCEDURE, THEY ADDED SOME TENSION TO THE GRAFT TO DE-AIR, HOWEVER, THE AIR WAS CONVERSELY PULLED INTO THE GRAFT. NO ADVERSE EFFECT ON THE PATIENT WAS REPORTED.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED DURING THE PROCEDURE, THEY ADDED SOME TENSION TO THE GRAFT TO DE-AIR, HOWEVER, THE AIR WAS CONVERSELY PULLED INTO THE GRAFT. NO ADVERSE EFFECT ON THE PATIENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93634 FUSION 8MM-40CM UNSUPP PERIPHERAL GRAFT PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER DSY MAQUET CV 25121992

    Patients

    Seq Age Sex Outcome Treatment
    1